A Phase II Study of Gemcitabine and Capecitabine in Advanced Cholangiocarcinoma and Carcinoma of the Gallbladder: A Single-Institution Prospective Study

Department of Medical Oncology, Roswell Park Cancer Institute, Buffalo, NY, USA.
Annals of Surgical Oncology (Impact Factor: 3.93). 12/2007; 14(11):3202-9. DOI: 10.1245/s10434-007-9539-9
Source: PubMed


To determine the clinical benefit response (CBR), time to tumor progression (TTP), overall survival, and effect on quality of life (QOL) of gemcitabine and capecitabine in patients with advanced biliary cancer.
Gemcitabine (1000 mg/m2 i.v. over 30 minutes on days 1 and 8) and capecitabine (650 mg/m2 orally twice daily for 14 days) were administered and repeated every 21 days. All patients completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and Pancreatic Cancer Module (EORTC QLQ-C30-PAN 26) questionnaire on day 1 of each cycle. Cumulative QOL scores were calculated. The two-stage design required 17 patients to evaluate the confirmed response at nine weeks.
Twelve patients with a median age of 54 years were enrolled. A median of eight cycles per patient were completed. With a median follow-up of 18.2 months, the CBR (two partial response and five stable disease) was 58% [95% confidence interval (CI) 28-85%]. Four out of seven patients with CBR had no decline in QOL with chemotherapy. The probability of survival at one year was 0.58. Median TTP and overall survival were 9.0 and 14.0 months, respectively. Nine patients had grade 3 or 4 toxicities. There were no treatment-related deaths.
Gemcitabine and capecitabine at this dose and schedule are well tolerated and effective and may offer clinical benefit and maintain QOL in patients with advanced biliary cancer. This regimen merits further investigation in the neoadjuvant setting.

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    • "However, the safety profile of sorafenib in our trial is acceptable in comparison with that observed in patients treated with chemotherapy. Several phase II clinical trials of gemcitabine plus cisplatin in advanced biliary tract carcinoma reported a grade 3 – 4 toxicity in the range of 33 – 75% (Thongprasert et al, 2005; Iyer et al, 2007; Meyerhardt et al, 2008). "
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    ABSTRACT: Advanced biliary tract carcinoma has a very poor prognosis, with chemotherapy being the mainstay of treatment. Sorafenib, a multikinase inhibitor of VEGFR-2/-3, PDGFR-beta, B-Raf, and C-Raf, has shown to be active in preclinical models of cholangiocarcinoma. We conducted a phase II trial of single-agent sorafenib in patients with advanced biliary tract carcinoma. Sorafenib was administered at a dose of 400 mg twice a day. The primary end point was the disease control rate at 12 weeks. A total of 46 patients were treated. In all, 26 (56%) had received chemotherapy earlier, and 36 patients completed at least 45 days of treatment. In intention-to-treat analysis, the objective response was 2% and the disease control rate at 12 weeks was 32.6%. Progression-free survival (PFS) was 2.3 months (range: 0-12 months), and the median overall survival was 4.4 months (range: 0-22 months). Performance status was significantly related to PFS: median PFS values for ECOG 0 and 1 were 5.7 and 2.1 months, respectively (P=0.0002). The most common toxicities were skin rash (35%) and fatigue (33%), requiring a dose reduction in 22% of patients. Sorafenib as a single agent has a low activity in cholangiocarcinoma. Patients having a good performance status have a better PFS. The toxicity profile is manageable.
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    ABSTRACT: The biliary carcinomas are malignant tumors infrequent, but nonexceptional, whose prognosis has been traditionally ominous short term by a double reason: its character clinically quiet until phases outposts of tumorlike invasion and their extensive local invasion in areas of difficult surgical boarding, like hilio hepático and the pancreaticoduodenal zone. The obstruction to the flor biliary it is the main consequence of his development in these anatomical locations, and its resolution frequently prolongs the life even in the absence of tumorlike resección. In the last years a remarkable progress in the techniques of interventionist radiology has taken place destined to palliate biliary obstruction by means of positioning of percutáneos transbiliares catheters or by endoscópica route; secured the ex- ternal or internal biliary drainage of this form to improve frequently the survival and avoids the opera- tion, that is curative in exceptional cases and is only taxed with an important morbidity and mortality in tumorlike jaundice. 80% of the patients with vesicle carcinoma have Colélitiasis, which suggests a etiológica relation between the presence of calculations and the later malignant degeneration of epite- lio of the biliary vesicle. Su prevalencía in autopsy material is of 0.5%; one is 4 times more in women than in men, in agreement with the relative frequency of Colélitiasis in both sexes. Su prevalencía he is also greater in the groups of population with high incidence of Colélitiasis, like the Indian tribes of the North American southwest and the Chileans. For the patient with Colélitiasis, nevertheless, the risk of malignant degeneration of the vesicle is small, since its incidence is only of 1%. For unknown reasons, this risk is substantially greater in patients with calcified vesicle (porcelain vesicle), reason why in this group the prophylactic colecistectomía is indicated. The average age of clinical presenta- tion oscillates around the 70 years.
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